ECTOPIA: Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

Sponsor
Maatschap Cardiologie Zwolle (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03845010
Collaborator
(none)
22
1
3
46.6
0.5

Study Details

Study Description

Brief Summary

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sotalol
  • Drug: Flecainide and verapamil
  • Procedure: Catheter ablation
N/A

Detailed Description

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized trial comparing catheter ablation with two different potent AADs with different engagement mechanisms in a 1:1:1 ratio with a crossover design in the AAD arm.Randomized trial comparing catheter ablation with two different potent AADs with different engagement mechanisms in a 1:1:1 ratio with a crossover design in the AAD arm.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment
Actual Study Start Date :
Feb 12, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sotalol

Drug: Sotalol
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)

Active Comparator: Flecainide and verapamil

Drug: Flecainide and verapamil
Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day

Active Comparator: Catheter ablation

Procedure: Catheter ablation
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine

Outcome Measures

Primary Outcome Measures

  1. Successful therapy [After 3 months]

    Number of patients reaching succesfull therapy defined as >80% reduction of of VPB/VT burden after 3 months

Secondary Outcome Measures

  1. VPB/VT burden [3, 6, 12 months after intervention]

  2. Change in VPB/VT burden [Before the intervention (baseline) and 3, 6, 12 months after intervention]

    Measurement in different subgroups e.g.: males, pre and post-menopausal women

  3. The impact in terms of total Quality of Life [3, 6, 12 months after intervention compared to baseline (before intervention)]

    Use of the University of Toronto AF severity scale (AFSS) questionnaire to measure Quality of Life. The total score range is 0-35. Seven questions in total with a maximum score of 5 points per question.

  4. Association between number of VPB/hour and heart rate (HR)/hour during 24-hours Holter- monitoring [At baseline]

    A scatterplot will be made in order to depict the association between the number of VBP/hour and heart rate (HR)/hour during 24-hour Holter-monitoring

  5. Number of pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in AAD arms with frequent visits and use of 24-hour Holter monitoring [3, 6 and 12 months after intervention]

  6. QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test [4-6 weeks after first administration of AAD]

  7. Complication rate of catheter ablation [Procedure and 3, 6 and 12 months after intervention]

    In all patients with special interest to the subgroup of patients with anatomically challenging origin of (non-RVOT) VPB/VTs

  8. Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement) [Baseline, 6 and 12 months after intervention]

  9. Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil [3, 6 and 12 months after intervention]

  10. Divide patients in three groups depending on HR dependency of VPB/VT and compare absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil [3, 6 and 12 months after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
76 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients willing and capable to provide written informed consent

  • Patients with frequent symptomatic VPB and/or nonsustained VTs with burden ≥ 5% on 24 hour Holter monitor AND

  • Absence of structural heart disease (excluded by echocardiogram) AND

  • Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND

  • Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician.

  • For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study

Exclusion Criteria:
  • Age >75 years

  • Previous catheter ablation therapy for VPB/VT

  • Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)

  • Wolff-parkinson-white (WPW) syndrome

  • Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol.

  • Left ventricular dysfunction (LV ejection fraction <55%)

  • Estimated glomerular filtration rate < 50 ml/min/1.73 m2

  • Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times ULN at screening

  • Untreated hypo- or hyperthyroidism or electrolyte imbalance

  • Untreated obstructive sleep apnea

  • Patients with history of myocardial infarction or bypass surgery

  • More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe)

  • Contraindication for any of the antiarrhythmic drugs used in this study

  • Enrolment in another clinical study

  • Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age

  • Mental or physical inability to participate in the study

  • Life expectancy ≤ 12 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Isala hospital Zwolle Netherlands

Sponsors and Collaborators

  • Maatschap Cardiologie Zwolle

Investigators

  • Principal Investigator: Arif Elvan, MD, PhD, Isala

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maatschap Cardiologie Zwolle
ClinicalTrials.gov Identifier:
NCT03845010
Other Study ID Numbers:
  • 10407
First Posted:
Feb 19, 2019
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022